Risk–benefit health assessment of food – Food fortification and nitrate in vegetables

Bottex, Bernard; Dorne, Jean‐Lou; Carlander, David; Benford, Diane; Przyrembel, Hildegard; Heppner, Claudia; Kleiner, Juliane; Cockburn, Andrew

doi:10.1016/j.tifs.2008.07.005

Cited by 25 publications

(14 citation statements)

References 6 publications

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“…Contrasting the concern for nitrosating species in various excipients, nitrates and nitrites are found at reactive levels in human saliva and stomach milieu. There is an endogenous pathway for the production of nitrates and nitrites as well as the availability of dietary nitrates (which are partially converted to nitrite endogenously) from fruits and vegetables, animal-based products such as processed meats, as well as water (49,50). Typical formulator concern for the production of potentially toxic drug-related NOC is limited to the generation of these species in the drug product; however, substantial formation can occur after ingestion as well, questioning the significance of the mitigation strategies employed for the drug product.…”

Section: Chemical Interactions Of Nitrite and Nitrate With Apimentioning

confidence: 99%

Reactive Impurities in Excipients: Profiling, Identification and Mitigation of Drug–Excipient Incompatibility

et al. 2011

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Reactive impurities in pharmaceutical excipients could cause drug product instability, leading to decreased product performance, loss in potency, and/or formation of potentially toxic degradants. The levels of reactive impurities in excipients may vary between lots and vendors. Screening of excipients for these impurities and a thorough understanding of their potential interaction with drug candidates during early formulation development ensure robust drug product development. In this review paper, excipient impurities are categorized into six major classes, including reducing sugars, aldehydes, peroxides, metals, nitrate/nitrite, and organic acids. The sources of generation, the analytical method for detection, the stability of impurities upon storage and processing, and the potential reactions with drug candidates of these impurities are reviewed. Specific examples of drug-excipient impurity interaction from internal research and literature are provided. Mitigation strategies and corrective measures are also discussed.

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Section: Chemical Interactions Of Nitrite and Nitrate With Apimentioning

confidence: 99%

Reactive Impurities in Excipients: Profiling, Identification and Mitigation of Drug–Excipient Incompatibility

et al. 2011

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“…Our results confirmed the previously described observation, about different factors such as exposure to sunlight or fertilization affecting a nitrate accumulation. Light intensity and nitrogen mineralization are widely recognized as important determinants of a nitrate level in vegetables, including cucumbers (Bottex et al 2008). As reported by Tamme and co-workers (Tamme et al 2010), vegetables grown in heated glasshouses have higher nitrate contents than those grown in the open air during the same season.…”

Section: Concentration Of Nitrites and Nitrates In Cucumber Fruit Extmentioning

confidence: 90%

Spectrophotometric Assessment of the Differences Between Total Nitrate/Nitrite Contents in Peel and Flesh of Cucumbers

2018

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A spectrophotometric method based on the reduction of nitrates to nitrites was applied to the determination of the difference between total nitrate and nitrite contents in the extracts from the cucumber peel and flesh. The content of these ions was determined in glasshouse cucumbers and those grown in the open fields, both marketed in Poland. Nitrate and nitrite extraction was performed using the Griess diazotization reaction and carried out according to the ISO recommendation (ISO 6635, 1984). It was observed that the mean nitrate content in the peel was significantly higher (p < 0.0001) than the mean nitrate content in the flesh. It was also proved that cucumber peel accumulated nearly threefold higher amount of nitrates than the flesh. The nitrite concentrations in all tested samples were below the limit of quantification. Despite statistically significant differences in the nitrate contents between the peel and the flesh, no excessive levels were found. A comparison of the current results to those reported for Poland and other countries is also presented.

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“…The Panel noted that this amount of nitrate corresponds to 0.6% of the ADI (3.7 mg/kg bw/day) for a 60 kg adult (SCF, 1992)). The additional amount of nitrate coming from consumption of food supplements appears limited but yet not advisable in the context of a chemical which is one of the four priorities identified by the WHO (2007) and taking into account the risks and benefits (Bottex et al 2008).…”

Section: Discussionmentioning

confidence: 99%

Chromium nitrate as a source of chromium added for nutritional purposes to food supplements

2009

EFS2

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Risk–benefit health assessment of food – Food fortification and nitrate in vegetables

Cited by 25 publications

References 6 publications

Reactive Impurities in Excipients: Profiling, Identification and Mitigation of Drug–Excipient Incompatibility

Reactive Impurities in Excipients: Profiling, Identification and Mitigation of Drug–Excipient Incompatibility

Spectrophotometric Assessment of the Differences Between Total Nitrate/Nitrite Contents in Peel and Flesh of Cucumbers

Chromium nitrate as a source of chromium added for nutritional purposes to food supplements

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